Acetic Acid Otic Solution, USP

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-09-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 21:53:28

Label at a glance#

ProductAcetic Acid

Active ingredientACETIC ACID

Label structure12 sections

Indications and uses

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

Dosage and administration

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Acetic Acid Otic Solution, USP is a solution of acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH₃COOH, with a molecular weight of 60.05. The structural formula is:

Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Acetic acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Hypersensitivity to acetic acid or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

WARNINGS

WARNINGS SECTION

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

PRECAUTIONS SECTION

Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

PEDIATRIC USE

SPL UNCLASSIFIED SECTION

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Carefully remove all cerumen and debris to allow acetic acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of acetic acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

HOW SUPPLIED

HOW SUPPLIED SECTION

Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL (NDC 50383-889-15) measured-drop, safety-tip plastic bottles.

STORAGE

SPL UNCLASSIFIED SECTION

Store at 20°- 25°C (68°-77°F). Keep container tightly closed.

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

Rev. 889:04 07/22

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50383-889-15

Acetic Acid Otic Solution, USP

15 mL

Rx only

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-889-15	2025-09-10	C162847	48780-1	1030e365-554f-111a-e063-dadaa90a10e2	Acetic Acid Otic Solution, USP
50383-889-15	2024-01-30	C162847	48780-1	1030e365-554f-111a-e063-dadaa90a10e2	Acetic Acid Otic Solution, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-889	ACETIC ACID SOLUTION [AKORN]	8	Legacy NDC	20220920_c53fc11e-b177-446e-839d-391e1b2eacff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-889-15	ML - Milliliter	50383-889	6dbe6614-0a52-4e15-9a38-8c5bb9ed81fd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETIC ACID	ACTIVE INGREDIENT	Q40Q9N063P	3
ACETIC ACID	ACTIVE MOIETY	Q40Q9N063P	3
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLENE GLYCOL DIACETATE	INACTIVE INGREDIENT	5Z492UNF9O	3
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Acetic Acid
PROPYLENE GLYCOL
BENZETHONIUM CHLORIDE
PROPYLENE GLYCOL DIACETATE
SODIUM ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50383-889	50383-889-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETIC ACID	Q40Q9N063P	ACTIB
PROPYLENE GLYCOL	6DC9Q167V3	IACT
BENZETHONIUM CHLORIDE	PH41D05744	IACT
PROPYLENE GLYCOL DIACETATE	5Z492UNF9O	IACT
SODIUM ACETATE	4550K0SC9B	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 122 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	CREAM / TOPICAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	12.5 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRADERMAL	1.6 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SUSPENSION / AURICULAR (OTIC)	0.68 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION/ DROPS / OPHTHALMIC	1.24 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	INJECTION / INTRAVENOUS		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRACAVITARY	0.1 ml		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL DIACETATE	PROPYLENE GLYCOL DIACETATE	5Z492UNF9O	SOLUTION/ DROPS / AURICULAR (OTIC)		46 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION / INTRAVENOUS		20 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION, SOLUTION / SUBMUCOSAL	0.08 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.03 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION, SOLUTION / INTRAVENOUS		328 mg	Exact identifier — unii candidate 32 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012179-001	VOSOL	ACETIC ACID, GLACIAL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OTIC		RLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N012179-001	VOSOL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012179-001	VOSOL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012179-001	VOSOL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012179-001	VOSOL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012179-001	VOSOL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012179-001	VOSOL	2%	SOLUTION/DROPS / OTIC	AT	RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012179-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012179-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012179-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012179-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012179-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012179-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012179-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012179-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012179-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012179-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012179-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012179-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012179-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012179-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012179-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012179-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012179-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012179-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012179-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012179-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012179-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012179-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012179-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012179-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012179-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012179-001	AT	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
68c0b983-a676-4ef0-ab06-c3670794edbe			c53fc11e-b177-446e-839d-391e1b2eacff	2025-09-10	Warnings, Adverse reactions	Exact identifier spl set id: c53fc11e-b177-446e-839d-391e1b2eacff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.